Green Tea Extract for Liver Cirrhosis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAiwu R He

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies the effects of a green tea extract on people with cirrhosis. The goal is to find the best dose and see if it can lower a molecule linked to liver cancer. By reducing this molecule, the treatment may help prevent liver cancer in these patients. Green tea extract has been shown to protect against various forms of liver damage, including those induced by alcohol, acetaminophen, and carbon tetrachloride.

Research Team

Aiwu R He

Principal Investigator

Northwestern University

Eligibility Criteria

Adults diagnosed with cirrhosis who can undergo imaging tests like ultrasound, CT, or MRI. They must have a good performance status (able to carry out daily activities), adequate blood counts and liver function, no history of certain cancers within the last 3 years except some localized ones, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with bleeding risks, allergies to green tea components, recent consumption of green tea products, other active cancers requiring systemic treatment or hepatic decompensation events.

Inclusion Criteria

I can undergo scans for my condition.

I am fully active or can carry out light work.

I do not have fluid buildup in my abdomen or brain function issues.

See 13 more

Exclusion Criteria

I am mentally capable of understanding and consenting to treatment.

Recent consumption of green tea-containing supplements or foods

I cannot swallow pills.

See 8 more

Treatment Details

Interventions

Defined Green Tea Catechin Extract (Cancer Preventive Agent)

Trial OverviewThe trial is testing defined green tea catechin extract's ability to prevent liver cancer in cirrhotic patients by lowering gamma-OHPdG levels. Participants will receive varying doses of this extract while being monitored through imaging studies and laboratory biomarker analysis for any changes in their condition.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Prevention (defined green tea catechin extract)Experimental Treatment9 Interventions

Participants receive defined green tea catechin extract PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound, CT, or MRI at screening and on study, undergo collection of blood samples on study, and may undergo biopsy at screening and on study.